MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ3 7MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Catalog Number 102453307

Device Problem Difficult to Insert (1316)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2023

Event Type  malfunction  

Event Description

It was reported that during the surgery, it was found that the insert could not be locked and it was easy to loosen and pull out.Replacing the insert caused that the procedure delayed by approximately 30 minutes.

Manufacturer Narrative

Product complaint # : (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: could not lock the insert.During the surgery, it was found that the insert could not be locked.And it was easy to loosen and pull out.After replacing another insert with the same lot number.The loosening situation happened again.Please check the detail in the video which is in the attachment.The doctor decided to continue to complete the surgery, but it may cause potential patient risk.Replacing the insert caused that the procedure delayed by approximately 30 minutes.The patient is stable now.The product was not returned to depuy synthes, however a video was provided for review.See attachment ""(b)(4)"".The video investigation revealed the device is loose on the mating component, however the allegation against the devices not fitting intra-op cannot be confirmed.Ifu-0902-00-806 explicitly states that "do not allow contact of any component with hard objects." and "damage or alterations to any implant component may produce stresses and/or cause defects which could lead to implant failure.", the surgeon is introducing another tool between the sigma hp uni ins sz3 7mm lm/rl and the tibial tray to demonstrate the loosening condition.It is important and stated in ifu-0902-00-806 "that a visual inspection of each implant component for possible imperfections should be performed".Furthermore it is important to note that the final decision of implantation is taken by the surgeon or surgical team and if a possible nonconformance was found on a device the most appropriate course of action would've been to stop the surgical process to diminish a possible risk to the patient.Additionally, with the evidence provided is unknown if there is any debris between the insert and tibial tray that might be contributing with the reported allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the [sigma hp uni ins sz3 7mm lm/rl] would contribute to the complained device issue.Based on the investigation findings, a potential cause cannot be established due to the limited information provided it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device jp2291 lot number, and no nonconformances were identified.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SIGMA HP UNI INS SZ3 7MM LM/RL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17513385
• MDR Text Key: 320922113
• Report Number: 1818910-2023-16612
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 10603295002536
• UDI-Public: 10603295002536
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102453307
• Device Lot Number: JP2291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1